Devices, systems, and methods for reshaping a heart valve annulus

Abstract

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the right atrium, which allow tricuspid valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant. The implants or systems of implants and methods may utilize a bridge stop to secure the implant.

We claim: 
     
       1. A method of placing an implant within a heart chamber comprising:
 deploying a guide wire in an intravascular path that extends from a first vascular access into the heart chamber and from the heart chamber to a second vascular access site different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site, 
 guiding a first catheter along the guide wire from the first vascular access site to a first bridge stop site within a wall of the heart chamber or adjacent vasculature; 
 deploying a first bridge stop at the first bridge stop site; 
 guiding a second catheter along the guide wire from the second vascular access site to a second bridge stop site within the wall of the heart chamber or adjacent vasculature; 
 deploying a second bridge stop at the second bridge stop site; 
 deploying a third bridge stop at a third bridge stop site within the wall of the heart chamber or adjacent vasculature with the first or second catheter; 
 coupling one end of a bridging element to the first bridge stop; 
 coupling another end of the bridging element to the second bridge stop; and 
 coupling the bridging element along an intermediate portion to the third bridge stop such that the bridging element spans across a single heart chamber, the single heart chamber comprising the respective heart chamber. 
 
     
     
       2. The method of  claim 1  wherein the heart chamber comprises a right atrium. 
     
     
       3. The method of  claim 1  further including placing the implant in tension within the heart chamber, thereby reshaping the heart chamber. 
     
     
       4. The method of  claim 1  wherein the implant comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue. 
     
     
       5. The method of  claim 1 , wherein the first, second and third bridge stop sites comprise any of the vena cava, the coronary sinus and a tissue wall of an adjacent ventricle. 
     
     
       6. The method of  claim 1 , further comprising:
 placing the bridging element in tension within the heart chamber so as to reshape a valve annulus of the heart chamber. 
 
     
     
       7. A method of placing an implant within a heart chamber comprising:
 deploying a guide wire in an intravascular path that extends from a first vascular access into the heart chamber and from the heart chamber to a second vascular access site different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site; 
 deploying an exchange catheter in an intravascular path defined by the guide wire, the exchange catheter being deployed over the guide wire and having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site; 
 coupling the implant to one end of the guide wire; and 
 pulling on the other end of the guide wire to pull the implant along at least a portion of the intravascular path through the exchange catheter and into the heart chamber, wherein pulling the implant into the heart chamber comprises pulling a bridging element of the implant across the heart chamber so that the bridging element extends from first and second bridge stops coupled to opposing end portions of the bridging element and to a third bridge stop coupled to an intermediate portion of the bridging element, wherein each of the first, second and third bridge stops are deployed within the wall of the heart chamber or adjacent vasculature such that the bridging element spans across a single heart chamber, the single heart chamber comprising the respective heart chamber. 
 
     
     
       8. The method of  claim 7  wherein the heart chamber comprises a right atrium. 
     
     
       9. The method of  claim 7 , further comprising:
 placing the implant in tension within the heart chamber thereby reshaping a valve annulus of the heart chamber so as to improve leaflet coaptation of the valve annulus. 
 
     
     
       10. The method of  9  wherein the bridging element comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue. 
     
     
       11. The method of  claim 7 , further comprising:
 coupling the bridging element along one end to the first bridge stop at a first end of the bridging element; 
 coupling the bridging element along a second end opposite the first end to the second bridge stop; and 
 coupling the bridging element along an intermediate portion between the first and second end portions to the third bridge stop. 
 
     
     
       12. The method of  claim 11 , further comprising:
 deploying each of the first and second bridge stops within the vasculature adjacent the heart chamber and deploying the third bridge stop within the wall of the heart chamber such that the bridging element spans across the heart chamber. 
 
     
     
       13. The method of  claim 11 , further comprising:
 placing the bridging element in tension within the heart chamber so as to reshape a valve annulus of the heart chamber. 
 
     
     
       14. The method of  claim 13 , wherein the first, second, and third bridge stops comprise one or more bridge stops deployed within the vena cava or the coronary sinus. 
     
     
       15. The method of  claim 13 , wherein the first, second, and third bridge stops comprise one or more ventricle bridge stops deployed at least partly within the adjacent ventricle. 
     
     
       16. The method of  claim 13 , wherein the heart chamber is the right atrium and the valve annulus is of the tricuspid valve, the method further comprising:
 deploying the first bridge stop within a superior vena cava of the heart; 
 deploying the second bridge stop within an inferior vena cava of the heart; and 
 deploying the third bridge stop within a ventricular tissue at or near the valve annulus. 
 
     
     
       17. The method of  claim 13 , wherein the heart chamber is the right atrium and the valve annulus is of the tricuspid valve, the method further comprising:
 deploying the first bridge stop within a superior vena cava of the heart; 
 deploying the second bridge stop within a ventricular tissue at or near the valve annulus; and 
 deploying the third bridge stop within an inferior vena cava of the heart. 
 
     
     
       18. The method of  claim 13 , wherein the first, second, and third bridge stops comprise one or more bridge stops deployed within the vena cava or the coronary sinus. 
     
     
       19. The method of  claim 13 , wherein the first, second, and third bridge stops comprise one or more ventricle bridge stops deployed at least partly within the adjacent ventricle. 
     
     
       20. The method of  claim 13 , wherein the heart chamber is the right atrium and the valve annulus is of the tricuspid valve, the method further comprising:
 deploying the first bridge stop within the superior vena cava; 
 deploying the second bridge stop within the inferior vena cava; and 
 deploying the third bridge stop, at least partly, within the right ventricle such that the bridging element crosses through or near a base of a leaflet of the tricuspid valve. 
 
     
     
       21. The method of  claim 11 , further comprising:
 deploying each of the first and third bridge stops within the vasculature adjacent the heart chamber and deploying the second bridge stop within the wall of the heart chamber such that the bridging element spans across the heart chamber.